Kornimate/medical-research-clean huggingface dataset:
clinical performance of the osia 3 sound processor compared with the osia 2 sound processor in adult osia implant users

Conditions: Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Conductive

Summary: this study aims to investigate the clinical performance of the osia 3 sound processor in comparison to the osia 2 sound processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an osia implant. participants will attend four study visits, where they will complete various hearing assessments using the osia sound processors.


Eligibility criteria:
inclusion criteria: * implanted with a cochlear osia implant (osi100 or osi200) * conductive or mixed hearing loss in the implanted ear. bone conduction threshold 4-frequency pure tone average (pta4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 khz) ≤ 55 db hl. or single-sided deafness in the implanted ear. air conduction threshold 4-frequency pure tone average (pta4; mean of air conduction thresholds at 0.5, 1, 2 and 3 khz) ≤ 20 db hl in the good ear. * aged 18 years or older, at time of consent. * minimum experience of 1 month with the osia 2 sound processor. * fluent speaker in the language used to assess speech perception performance. * willing and able to provide written informed consent. exclusion criteria: * sensitivity to loud sounds. * ongoing infection at or around the sound processor area. * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation).
optical surface imaging versus conventional photography as a tool to document the surface geometry of pectus excavatum

Conditions: Pectus Excavatum; Funnel Chest

Summary: pectus excavatum is the most common congenital anterior chest wall deformity, known to occur in 1:400 of new-borns. complaints may be of cosmetic nature or as a consequence of (cardio)pulmonary impairment. part of the current work-up of pectus excavatum patients in zuyderland medical centre (heerlen, the netherlands) is visual documentation of the deformity. visual documentation is performed utilising a single-reflex camera and consists of 5 standard photographs (acquired from different angles) and two specialised recordings. these specialised recordings encompass a recording to measure the pectus excavatum's depth and a raster stereography recording to create a three-dimensional perspective. however, this form of visual documentation is not efficient, as it is time- and labor-intensive for the photographer and patient. recently, another study started that aims to investigate whether three-dimensional (3d) optical surface scans can be used to determine pectus severity, as compared to chest radiographs and computed tomography scans (3dpectus study; metcz20190048; nct03926078). building on this study it was determined whether 3d optical surface scans can be used as a tool to document the surface geometry of pectus excavatum. to determine whether the current standard photographs and specialised recordings can be replaced by a 3d scan, both methods are compared. to make this comparison, the pectus excavatum depth was chosen as an objective measure of agreement. if there is good agreement, it is assumed that the standard photos can be replaced by a 3d photo in the current work-up. this will subsequently result in a time saving as well as a reduced burden for the patient while acquisition of 3d scans takes only 10 seconds.


Eligibility criteria:
inclusion criteria: * all participants of the 3d pectus study (metcz20190048; nct03926078) that received a 3d scan and standard photographies. exclusion criteria: * participants in which the photography based pectus excavatum depth was measured in the transversal plane.
oral glucose intervention for children with gastroenteritis and ketosis

Conditions: Gastrointestinal Infections; Ketosis

Summary: fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. the investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

more than 1.7 million children with acute gastroenteritis present for emergency department (ed) care annually in the united states. gastroenteritis treatment regimens have been outlined in guidelines endorsed by the american academy of pediatrics, european society of pediatric gastroenterology hepatology and nutrition (espghan), and center for disease control (cdc). a fundamental principle included in these guidelines is the administration of oral rehydration therapy (ort) to the vast majority of children with gastroenteritis; however, surveys have shown that a gap exists between guidelines and practice. fasting ketoacidosis is an increasingly recognized metabolic derangement for children presenting with symptoms suggestive of gastroenteritis and mild to moderate dehydration. ketoacidosis frequently occurs and likely adds comorbid symptoms of lethargy, vomiting, and malaise. these symptoms likely impair successful oral rehydration interventions. these symptoms may also lead to overestimations of the severity of dehydration. rapid recognition of ketoacidosis is now possible with point of care testing beta-hydroxybutyrate. this investigation will determine if an oral glucose gel intervention will improve the point of care (poc) beta-hydroxybutyrate from baseline. secondary outcomes measured will include net fluid volume intake estimates, need for iv hydration, and need for hospitalization.

Eligibility criteria:
inclusion criteria: * participants with gastroenteritis presenting to uf health shands emergency department exclusion criteria: * hypoglycemic- blood glucose less than 50 or hyperglycemic- greater than 200

Keywords: ketones gastroenteritis
caloric restriction in sarcoma patients treated with pre-operative rt

Conditions: Tumor Surgery

Summary: this study is being conducted to decrease the rate of surgical wound complications. the investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.

the goal is to decrease the chance of having wound complications after surgery. caloric restriction has been found to be a natural modifier of surgical outcomes. participants will be randomize into the arms caloric restriction diet or normal diet.

Eligibility criteria:
inclusion criteria: * age \>18 years * biopsy proven soft tissue sarcoma located in the lower extremities * patient to be treated with radiation therapy for a primary lower extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection * karnofsky score ≥ 60% * body mass index (bmi) ≥ 20 kg/m2 * protein levels within normal limits within 45 days of enrollment * normal kidney and liver function within 45 days of enrollment * normal blood counts within 45 days of enrollment * normal chemistries within 45 days of enrollment exclusion criteria: * current pregnancy and breast feeding * other cancers diagnosed within the last 5 years (in situ and/or invasive) * diabetes mellitus * current metformin therapy * other conditions may exclude participants from the study (e.g. intractable nausea/emesis, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)

Keywords: surgery
formoterol-beclomethasone in patients with bronchiectasis: a randomized controlled trial

Conditions: Bronchiectasis

Summary: randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200 mcg bid versus placebo to evaluate the clinical effect on coughing in patients with non-cystic fibrosis (non-cf) bronchiectasis, native to inhaled corticosteroid (ics) therapy and no history of asthma or chronic obstructive pulmonary disease (copd)

in the management of non-cf bronchiectasis, bronchodilator treatment (laba)and use of inhaled corticosteroids (ics) is still a matter of debate. previous studies have claimed beneficial effects of ics (with or without bronchodilator), such as improvement of the hrql, a reduction in daily sputum volume and/or exacerbation frequency. however, in all previous studies there was no clear exclusion of patients with asthma or copd, or no use of placebo. the current study will be the first study evaluating the effect of ics/laba treatment in non-cf bronchiectasis excluding patients with asthma and copd. this is a prospective double-blind randomized controlled trial comparing formoterol-beclomethasone 12/200 mcg bid versus placebo to evaluate the reduction in cough measured by the leicester cough questionnaire. secondary objectives are the improvement of health-related quality of life and symptoms, reduction in sputum production, pulmonary function (fev1) and the frequency of exacerbation. furthemore, we will assess the inflammatory response in serum and sputum. after a wash-out period of 1 month, eligible subjects will be randomized to treatment with formoterol-beclomethasone or matching placebo. all subjects will be treated with the regimen of medication for 3 months. an end-of-study (eos) visit will be performed after completion of the follow-up period.

Eligibility criteria:
inclusion criteria: * symptomatic patient (wheezing, cough and dyspnoea); * proven and documented diagnosis of be by high resolution computed tomography ; * stable pulmonary status as indicated by fev1 (percent of predicted) ≥30% * stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study); * stable regimen of standard treatment as chronic treatment for be, at least for the past 4 weeks prior to screening. and/or macrolides if used as chronic treatment for be at least for the past 6 months prior to screening; * coughing on the majority of days for more than 8 weeks; * ability to follow the inhaler device instructions; * ability to complete questionnaires; * written informed consent. exclusion criteria: * possible asthma according to the definition of the global initiative for asthma (gina); * positive histamine provocation test * known intolerance for ics or laba; * women who are pregnant, lactating, or in whom pregnancy cannot be excluded; * expected to die within 72 hours after enrolment; * cigarette smoking history of \> 10 pack-years or current smokers; * other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values.

Keywords: randomized controlled trial inhaled corticosteroids placebo cough
myprostatescore equivalency with and without dre

Conditions: Prostate Cancer

Summary: the purpose of the study is to quantify the concordance of mps results between first-catch urine samples collected post-dre and those collected without a dre.

the process for obtaining a urine sample for mps currently requires a dre within one hour prior to urine collection. we aim to understand whether a dre is a required step prior to urine collection for mps, and to explore alternative methods that may eliminate the need for a dre. in order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.

Eligibility criteria:
inclusion criteria: * patient is a candidate for prostate biopsy (bx) * if bx naïve and ≤75yo then psa 3-10 ng/ml * if bx naïve and \>75yo then psa 4-10 ng/ml * if prior negative bx then psa may exceed 10 ng/ml * if dre very suspicious, then psa below the thresholds of 3 ng/ml (≤75yo) and 4 ng/ml (\>75yo) are acceptable exclusion criteria: - prior diagnosis of prostate cancer

Keywords: biomarker tumor prostate prostatic neoplasm prostate-specific antigen early detection of cancer
comparison of in vitro fertilization rates of oocytes and embryo development using two techniques of semen processing

Conditions: Infertility, Female

Summary: the investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: sperm selection assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. we will assess in vitro fertilization with two techniques (sssa versus traditional technique of swin up) as well as embryo development.

the project is a rct follow the orientation of consort. the investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: sperm selection assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. we will assess in vitro fertilization with two techniques (sssa versus traditional technique of swin up) as well as embryo development.

Eligibility criteria:
inclusion criteria: * infertile women who will partcipate in an ivf programme exclusion criteria: * male factor of infertility
linagliptin among filipino patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of linagliptin among filipino patients with type 2 diabetes mellitus (dm) within the study duration of 24 weeks.


Eligibility criteria:
inclusion criteria: 1. filipino of asian race 2. patient using linagliptin within label or locally approved indication. the prescription of linagliptin to the patient must be in the course of normal clinical practice and independent of the decision to include the patient in the study. 3. male or female patients more than 18 years old 4. body mass index less than or equal to 40 5. diagnosed with type 2 dm 6. uncontrolled type 2 dm with fasting blood sugar of more than 126 mg/dl and/or hba1c more than 7%. exclusion criteria: 1. diagnosed with type 1 dm 2. patients with acute illness requiring hospitalization in the past one month 3. patients participating in a different study that includes an investigational drug 4. patients with known hypersensitivity reaction to linagliptin or any of tis components 5. pregnant women and those women who have intentions of getting pregnant within the study duration 6. nursing women 7. patients with concomitant conditions that contraindicates linagliptin use as described in its product information
the impact of resuscitation quality of cpr team by implantation of electronic checklist and alarming system through video-recording analyses

Conditions: Cardiopulmonary Arrest

Summary: the quality of cardiopulmonary resuscitation (cpr) has been identified as an important determinants for patient survival, yet many studies revealed poor cpr guidelines compliance in real-life practice for both health care providers and lay persons. common shortcomings identified include an insufficient number of chest compression, too rapid lung inflations, and too much hands-off time. the poor quality of cpr is associated with lower survival rate. besides, some other problems could be found during resuscitation, such as prolonged intubation time, delayed first shock delivery or unsteady drug delivery interval. these problems can't be blamed on the only person but the teamwork. certain measurements could improve the performance of the resuscitation team, such as audio prompt or checklist. methods proposed and improvised to improve the quality of cpr have included cpr assisted devices, automatic driven devices or audio prompt system. however, some of these methods are hardly incorporate with the original resuscitation process since it could be an extra workload. therefore, the investigators try to provide an digitized checklist combined with visual and audio alarming system, which could not only minimize the workload of chart recording but also remind the team to perform essential procedures in time. information gained from a video-recording evaluation system had been employed to improve the resuscitation skills. the improvement of resuscitation quality also could be found through video-recording after certain intervention. it can also avoid the interference of the resuscitation and find out other harmful factors to cpr quality.


Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest patient present to ntuh ed * age \> 18 years old * e-checklist system applied exclusion criteria: * e-checklist system not applied * video not been recorded

Keywords: cardiopulmonary resuscitation teamwork electronic checklist
efficacy and safety of cettum for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is verify the efficacy and safety of cettum (electric moxibustion) for patients with knee osteoarthritis.

the investigator targets the patients with knee osteoarthritis. after treatment in 3 groups - cettum treatment, traditional indirect moxibustion treatment, and usual care groups - the investigators will compare the effects of pain relieving and daily performing improvement. so the investigators will confirm the efficacy of cettum, and further the best treatment method. in addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility criteria:
inclusion criteria: 1. at least 40 years of age, but below 70 years of age 2. presence of knee osteoarthritis diagnosed according to american college of rheumatology classification criteria and satisfying the following 2 conditions * knee pain when weight load in one or both knees in the last 6 months * knee pain rated \>4cm on a 10cm visual analog scale (vas) 3. feeling temperature sense to distinguish temperature differences 4. an understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form 5. those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months exclusion criteria: 1. trauma to the knee(s) within 6 months prior to enrollment, causing pain or functional problems 2. surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems 3. a history of intra-articular injection within the last 3 months 4. a physical or laboratory finding indicating presence of an inflammatory arthritis (e.g. rheumatoid arthritis, autoimmune disease) 5. presence of physical or psychiatric disorder that may affect moxibustion treatment 6. presence of neurological disorder including paralysis symptoms on local or general sensation 7. a female who is pregnant or is lactating 8. being afraid of moxibustion treatment or expected to cause side effects 9. when researchers evaluate that it is not appropriate to participate in this clinical test

Keywords: osteoarthritis, knee moxibustion
low-intensity resistance exercise and diet on arterial function and blood pressure

Conditions: Obesity; Pre-hypertension; Hypertension

Summary: * obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. however, along with decreases in fat mass, hypocaloric diet reduces muscle mass. low-intensity resistance exercise training (liret) results in similar increases in muscle mass and strength than those observed after high-intensity resistance exercise. * the investigators hypothesis is that weight loss via diet combined with liret would additively reduce arterial stiffness and blood pressure (bp) in obese women. the investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in bp regulation.

the purpose of the study is to examine the effects of 12 weeks of low-intensity resistance exercise training (liret) and diet on arterial function, autonomic function, and body composition in obese women with high blood pressure (bp). specific aims of the study are to: * to evaluate the extent to which diet and liret will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference. * to investigate that combined diet and liret are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic bp and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity \[low-frequency power of systolic bp variability\], and baroreflex sensitivity). circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (no metabolites \[nox\] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin f2α) will be assessed as secondary outcome variables.

Eligibility criteria:
inclusion criteria: * female * 40 to 65 years of age * body mass index of 27-39.9 * sedentary or low active (less than 2 hr per wk) exclusion criteria: * younger than 40 or older than 65 years of age * body mass index lower than 27, or 40 or higher * physically active or competitively active * smoker * systolic blood pressure higher than 140 mmhg * use of hormone replacement therapy of less than 1 yr * use of calcium channel blocker or beta blockers * type 1 diabetes * uncontrolled type 2 diabetes

Keywords: low intensity resistance exercise training hypocaloric diet prehypertension hypertension obesity arterial function arterial stiffness pulse wave velocity autonomic function endothelial function adipocytokines
development and evaluation of a cognitive rehabilitation program for persons with multiple sclerosis

Conditions: Multiple Sclerosis; Cognitive Impairment

Summary: multiple sclerosis (ms) is a progressive neurological disease that affects over 2.5 million people worldwide. up to 50% of persons with ms (pwms) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. ms-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. thus, pwms who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age. management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. considering the high frequency of cognitive impairments in ms and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of ms rehabilitation. the overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for pwms.


Eligibility criteria:
inclusion criteria: * diagnosis of ms * 18 years of age or older * self-report of cognitive difficulties exclusion criteria: * exacerbation of symptoms in past 3 months * history of tbi, cva, epilepsy, psychiatric condition, drug/alcohol abuse

Keywords: multiple sclerosis cognitive impairment self-management programs occupational therapy rehabilitation